RecruitingACTRN12623001172695

HYPO-BL: Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial – Ultra versus Moderate Breast Hypofractionation Radiation Treatment

Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial – Ultra versus Moderate Breast Hypofractionation Radiation Treatment (HYPO-BL)


Sponsor

Gosford Hospital

Enrollment

200 participants

Start Date

Aug 12, 2024

Study Type

Interventional

Conditions

Summary

This study aims to determine the incidence of breast oedema following whole breast radiotherapy using an objective measure of TDC measurements, to determine the difference, if any, between a moderately hypofractionated radiation schedule and an accelerated ultra-hypofractionated schedule. Who is it for? You may be eligible for this study if you are a woman aged 50 years or older and have been diagnosed with breast cancer. Study details Participants will be randomised to one of two possible treatments: the current standard of care of "moderate hypofractionation" treatment, as 40.05 Gy in 15 fractions as daily treatment sessions for 15-19 consecutive days; or " ultra-hypofractionation" treatment, as 26 Gy in 5 fractions to the whole breast, delivered in 5 sessions over 5-9 days. A tumour bed boost is an optional component of both treatments. Participants will be followed for 60 months after the treatment to determine post-radiotherapy breast changes, such as swelling and oedema, quality of life and other patient reported outcomes. It is hoped that this research will help to improve the safety, patient experience, and efficacy of breast cancer treatment.


Eligibility

Sex: FemalesMin Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

After breast cancer surgery, most women receive radiotherapy to reduce the risk of the cancer coming back. Radiation can sometimes cause the breast tissue to become swollen or puffy — a condition called breast oedema or lymphoedema — and this can affect appearance, comfort, and quality of life. A newer, shorter radiotherapy schedule (called ultra-hypofractionation, 5 treatments over 1 week) may be just as effective as the standard 15-treatment schedule while being more convenient. However, it is not yet clear whether the two schedules cause the same amount of breast swelling. This study will measure breast tissue water content using a painless, handheld device before and after treatment to objectively compare swelling between the two schedules. Participants will be followed for 5 years to also assess quality of life, cosmetic outcomes, and cancer control. You may be eligible if you are a woman aged 50 or older with early-stage breast cancer (including DCIS) who has had breast-conserving surgery (a lumpectomy) with clear margins and does not require lymph node radiation. Women with a history of previous breast cancer, breast implants, or reconstructive surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study is enrolling 200 patients. If the patient meets the inclusion criteria of the study as per radiation oncologist they can be randomised onto the study via an electronic system. There is

The study is enrolling 200 patients. If the patient meets the inclusion criteria of the study as per radiation oncologist they can be randomised onto the study via an electronic system. There is a 50/50 chance of being randomised into either arm of the study. Radiotherapy treatment could either be 5-9 or 15-19 days. In the shorter course arm, patients will receive radiotherapy delivered by radiation therapists at Gosford Hospital at a dose of 26.0Gy in five fractions with an optional tumour bed boost (This optional boost is decided by the Radiation Oncologist). This tumour bed boost can be given simultaneously as 30Gy in five fractions or sequentially as 10Gy in four fractions. The overall duration of the intervention is over 5-9 days.


Locations(1)

Gosford Hospital - Gosford

NSW, Australia

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ACTRN12623001172695


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